Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00496392
First received: July 3, 2007
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

Primary:

• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.

Secondary:

  • To compare patients' general impression and preference of NF and Actiq
  • To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid
  • To assess safety and tolerability of NF

Condition Intervention Phase
Pain
Drug: Nasal fentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 115
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nasal fentanyl
    Breakthrough pain in patients with breast or prostate cancer
    Other Name: Instanyl
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.
  • Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.
  • Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.
  • Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.
  • Previous use of Actiq is accepted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496392

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

No publications provided by Nycomed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00496392     History of Changes
Other Study ID Numbers: FT-019-IM, 2006-002087-26
Study First Received: July 3, 2007
Last Updated: May 4, 2012
Health Authority: France: Ministry of Health
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: National Health Service

Keywords provided by Nycomed:
breakthrough pain in patients with cancer

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 18, 2014